Industry Reactions to NDI Guidance

The natural products industry has been dissecting the proposed guidelines for new dietary ingredients (NDIs) since the U.S. Food and Drug Administration (FDA) made them public in July. Last month, WholeFoods explained some of the technical parts of the document and what they could mean for supplement makers. But, there’s another side of the story: the human side, specifically how companies are reacting to the document.

October Deadline “Grossly Inadequate”
First, many feel that companies need more time to go through the draft guidance before they can submit meaningful comments to the agency. This month, FDA had originally planned to close its comment period, but this three-month timeline from when the document was issued was seen as far too tight. In August, several trade associations filed a request with the agency for extra time. While the group—comprising the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the United Natural Products Alliance—said “we applaud FDA for the release of this document,” the associations feel more time is needed. The group requested a 45-day extension to November 17. Just before press time, FDA responded to this request with a 60-day extension (to December 2, 2011).

According to Duffy MacKay, N.D., CRN’s vice president of scientific and regulatory affairs, the extension request was made because “everyone has their own different perspective on this guidance document so we need ample time to have a discussion and set the framework for a draft of our comments.” Then, the group would collect input on and revise its document, he states. “The guidance document is very robust, is very detail oriented and is long, so we just want to make sure no stone is left unturned,” says MacKay.

He adds that this is a lesson learned from the dietary supplement good manufacturing practices document. In the preamble, FDA says it made several points to which it says the industry did not respond during the comment period and so it felt justified in setting in stone some policies without adjustment. “We really want to make sure we address all aspects of this guidance document,” MacKay states.

He also anticipates the trade associations will combine efforts to see which key points they all agree on and submit a combined letter to FDA that would reflect the thoughts of the entire industry for maximum impact. This, of course, would require some additional time to do so.

Before this request was made, others also pushed FDA to extend the deadline. But, in its September 2 notice alerting industry of the new deadline, it only referred to the trade associations’ request. In fact, the law firm Hyman, Phelps & McNamara, P.C. asked to have until at least July 5, 2012 to submit comments, considering the possible deep ramifications the document could have on the industry. The group makes the point the FDA took 17 years to prepare the document and “a 90-day comment period is grossly inadequate.” They feel a year-long comment period is “essential” and is justified because “there is no apparent and certainly no urgent public health need for a shorter period, given that FDA already has numerous tools to identify safety issues relating to dietary ingredients and to remove dietary ingredients that present any safety concerns from the market.”

Also concerned with the 90-day deadline was Jarrow L. Rogovin, president and chairman of the board of Jarrow Formulas, Inc., and chairman of the board for Jarrow Industries, Inc. Rogovin also requested an extension to July 5, 2012, “given the scope of the draft guidance, its transformative effects, its complexity, and its potential impact.” He makes the point that the agency previously allowed for a full year of comments on FDA’s Proposed Rule for Dietary Supplement Good Manufacturing Practices; the NDI document, he feels, could have an even greater impact on the industry and thus warrants a similar time period for comments.

But MacKay stands behind the trade associations’ request of 45 days calling it “reasonable.” “We didn’t want to seem belligerent to FDA in asking for a very long time,” he states, noting that industry has asked for this document to be developed for quite some time. “We thought it would be a bit disingenuous to then turn around and say, ‘Wait a minute. We want a year to respond.’”

FDA did not indicate why it only considered the 45-day request in its final decision.

Document Angers Supplement Supporters
The NDI guidance has elicited numerous passionate responses from advocates of dietary supplements. One overarching concern is the duplicative nature of the document, which requires repetitive notifications on the same ingredient from various companies. Plus, the “grandfathered-in” lists of ingredients from the trade associations seem to be off the table for now; rather, FDA is looking for proper documentation like receipts that products were sold before 1994 from each company.

An official comment to FDA came from Danielle S. Baumgart, president of Priority One Nutritional Supplements, Inc. She states that requiring an NDI application for each ingredient, formulation change or combination product with a NDI would “stifle business, close a huge section of industry and add millions of dollars in cost to FDA. And in the end, it does not address manufacturing process or safety issues for real adulteration by drugs, chemicals or steroids.” Several comments to FDA also express concerns over the effect the guidelines could have on small businesses.

Like many others, Baumgart also feels that the guidance ignores the original intention of DSHEA. Mark Davis, a naturopathic doctor, states, “Herbs and vitamins are regulated as foods, not as drugs, because their potential side-effect profiles are miniscule compared with that of most pharmaceuticals. On the other hand, these products can be enormously therapeutic, and stifling their manufacturers’ freedom to combine them, change doses and make small manufacturing changes seems overly burdensome to manufacturers and distributors as well as obstructive to doctors who use them therapeutically.”

Bill Sardi of Knowledge of Health, Inc., calls into question numerous logistical problems with the document. Among them, FDA has stated 56,000 dietary supplements are sold in the marketplace today, and only 700 have submitted NDI notifications. Says Sardi, “Assume that NDI compliance efforts produce 40,000 NDI submissions over a 3-year period. Just how would FDA anticipate timely review given such a high volume of NDI submissions? At 240 workdays per year, not counting re-evaluations, the FDA would have to review and approve/disapprove 55 NDI submissions per day.” Plus, he states, “it may take years of testing before a new dietary supplement could be marketed.” Likewise, others question whether FDA has the manpower to enforce this document fairly, given it is obligated to respond to notifications within 75 days.

Meanwhile, New York City law firm Ullman, Shapiro & Ulman, LLP submitted comments to FDA arguing that the agency’s “Analysis of Impacts” doesn’t match with its proposed guidance. In 1997, the agency stated that NDI regulation won’t significantly impact companies (particularly small businesses) from an economic standpoint because the number of new ingredients would be just 0–12 per year. Given that the new document requires NDI notification for every supplement that contains an NDI, its previous estimation is way off. Thus, the firm suggests that the new document is at odds with its prior analysis, and should be withdrawn.

Some 78 official comments had been filed as of press time; additional comments will likely be submitted as the December deadline approaches.

FDA Policies Called into Question
The issuing of the draft guidelines has been called an assault on the dietary supplement industry. In fact, in this month’s Vitamin Connection column (see page 48), attorney Jonathan Emord, Esq., outlines the many ways that FDA has recently threatened the industry, and this includes the NDI document. “They are not just threats; actions are now underway that will cause many dietary supplement companies that make safe and valuable products to disappear from the market,” he states.

And in this month’s Legal Tips column (see page 53), Scott Tips issues a call to action for industry to fight the document, noting that “everyone with even an ounce of common sense has grave concerns about [it].”

Also hoping to inundate FDA with letters is a new Web site, www.operationpushback.com, that wants supplement supporters to “help us flood Congress with letters and demands that the FDA's tyranny against dietary supplements be stopped.” The group feels FDA is acting inappropriately by blocking products with requirements that it feels are onerous and costly.

Rogovin also feels FDA is acting inappropriately, specifically with the hiring of its new director of dietary supplement programs, Daniel Fabricant, Ph.D., formerly vice president of scientific and regulatory affairs at the NPA. In a 15-page letter to FDA Commissioner Margaret Hamburg, Rogovin states that it is a conflict of interest for FDA to hire a former trade association executive for such a high-level decision-making position. He states that during his tenure at the NPA, Fabricant had access to numerous confidential exchanges of information and legal analyses that he could now potentially use against the supplement industry. “It is categorically impermissible for a regulatory agency to recruit its top compliance and regulatory officers from the top executive management of trade association of the very same industry that the agency regulates,” he writes in the letter. “What the agency has done is a direct attack on the very concept and role of a trade association.” Rogovin spells out how he believes Fabricant has acted inappropriately toward the supplement industry, including a pre-judging of comments yet to be filed on the NDI guidance.

Rogovin has also announced that his company will be issuing a request under the freedom of information act (FOIA) to probe into the hiring of Fabricant. He also suggested that Fabricant be moved to another office that doesn’t deal with dietary supplements.

When asked for comments, Stephen King, FDA spokesperson, told WholeFoods Magazine that FDA’s ethics and integrity staff was consulted during the hiring of Fabricant about any potential impartiality issues.

Added King, “As with all new FDA employees who come to the Agency from a position in a regulated industry, FDA requires that Dr. Fabricant recuse himself from affairs involving certain individuals or organizations for whom he served as an officer, director, trustee, general partner, agent, attorney, consultant, contractor, or employee in the 12 months proceeding his hire. Therefore, absent specific authorization, Dr. Fabricant would not participate in an official matter involving a specific party with whom he has had a covered relationship or represents a party to the matter.”